Description

Tenofovir Disoproxil Fumarate Impurity N is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the safety and efficacy of Tenofovir Disoproxil Fumarate (TDF) active pharmaceutical ingredients (APIs) and finished drug products by enabling accurate identification and quantification of this specific impurity. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and quality assurance of antiviral medications.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the qualitative and quantitative analysis of Tenofovir Disoproxil Fumarate (TDF) during method development and validation.
• Quality Control (QC) Testing: Used as a primary standard in routine QC laboratories to monitor and control the levels of Impurity N in TDF API batches, ensuring compliance with pharmacopeial limits (e.g., USP, EP).
• Stability Studies: Employed to track the formation and growth of this specific degradation product in TDF formulations under various stress conditions (e.g., heat, humidity, light).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies for TDF-based drug products.
• Research and Development (R&D): Facilitates research into the degradation pathways, synthesis, and toxicological profile of Tenofovir Disoproxil Fumarate and its related substances.
• Method Transfer and Laboratory Qualification: Acts as a critical tool for calibrating equipment and qualifying analytical methods when transferring QC procedures between sites or to contract research organizations (CROs).

Basic Information

Product Name	Tenofovir Disoproxil Fumarate Impurity N
CAS No.	1962114-92-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tenofovir Impurity N; TDF Impurity N; 9-[(R)-2-[[Bis[[(isopropoxycarbonyl)oxy]methoxy]phosphinyl]methoxy]propyl]adenine fumarate impurity; Tenofovir Disoproxil Fumarate Related Compound N; Bis(POC) Tenofovir Impurity N; (R)-PMPA Bis(POC) Impurity N; Tenofovir Disoproxil Related Substance N
EINECS	Contact for details

Quality Control

Every batch of Tenofovir Disoproxil Fumarate Impurity N is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assessment, and impurity profiling using advanced analytical techniques such as HPLC, GC, and NMR to ensure it meets the stringent requirements for a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. The material should be kept in a dry environment. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.